Investigation of treatment continuity, usefulness, and nocebo effect in switching from the original etanercept to its biosimilar in patients with rheumatoid arthritis: A JET observational study in Japanese clinical practice.

Objectives: To assess the usefulness and onset of nocebo effects after switching from the original etanercept (ETN) to a biosimilar (BS) in routine clinical practice at rheumatology clinics in Japan (13 sites).

Methods: A total of 165 patients (87.0% women, age = 57.

Efficacy and tolerability of subcutaneously administered methotrexate including dose escalation in long-term treatment of rheumatoid arthritis in a Japanese population.

Objectives: The aim of this article is to evaluate the efficacy and safety of subcutaneously administered methotrexate (MTX) for Japanese patients with active rheumatoid arthritis.

Methods: MTX-naïve patients were randomized in a 1:1 ratio to receive a 12-week administration of either 7.5 mg MTX subcutaneously (MJK101, a prefilled syringe for subcutaneous injection) or 8 mg MTX orally in Part 1 of the trial.

Oral and Intestinal Bacterial Substances Associated with Disease Activities in Patients with Rheumatoid Arthritis: A Cross-Sectional Clinical Study.

Intestinal bacterial compositions of rheumatoid arthritis (RA) patients have been reported to be different from those of healthy people. Dysbiosis, imbalance of the microbiota, is widely known to cause gut barrier damage, resulting in an influx of bacteria and their substances into host bloodstreams in animal studies. However, few studies have investigated the effect of bacterial substances on the pathophysiology of RA.

Weekly split-dose regimen for oral methotrexate reduced polyglutamation in red blood cells in patients with rheumatoid arthritis compared with single-dose regimen: Results from a multicentered randomized control trial.

Aims: We compared the incidence of adverse events between single and divided-dose regimens of methotrexate (MTX) by using a multicenter randomized controlled trial.

Methods: Eighty-nine patients with insufficient control on MTX 8 mg/wk were randomly assigned into single-dose (39 patients) or triple dose (39 patients) groups. The MTX dose for all patients was gradually increased to 16 mg/wk.

Efficacy and safety of sodium RISedronate for glucocorticoid-induced OsTeoporosis with rheumaTOid arthritis (RISOTTO study): A multicentre, double-blind, randomized, placebo-controlled trial.

Objective: No evidence has shown the efficacy of Sodium Risedronate (Risedronate) for glucocorticoid-induced osteoporosis (GIO) in patients with Rheumatoid arthritis (RA). The aim of this study was to explore the effectiveness and safety of Risedronate for GIO complicated with RA.

Methods: This was a six-month randomized, double-blind, placebo-controlled trial of 95 patients with GIO complicated with RA from 19 centers.

Efficacy and safety of peficitinib (ASP015K) in patients with rheumatoid arthritis and an inadequate response to methotrexate: results of a phase III randomised, double-blind, placebo-controlled trial (RAJ4) in Japan.

Objective: To evaluate the efficacy and safety of the oral Janus kinase (JAK) inhibitor peficitinib versus placebo in Japanese patients with rheumatoid arthritis (RA).

Methods: In this multicentre, double-blind, parallel-group, placebo-controlled phase III study, patients with RA and inadequate response to methotrexate (MTX) were randomised 1:1:1 to placebo, peficitinib 100 mg once daily or peficitinib 150 mg once daily with MTX for 52 weeks. Based on baseline randomisation, at week 12, non-responders receiving placebo were switched to peficitinib until the end of treatment; the remaining patients were switched to peficitinib at week 28.

Choice of the most appropriate biological disease-modifying anti-rheumatic drug for injection spacing: results from a multicentre observational study.

Objectives: To determine which biological disease-modifying anti-rheumatic drug (bDMARD) is most appropriate for spacing in patients with rheumatoid arthritis (RA) who have persistent stable symptoms.

Methods: In patients with sustained low disease activity (LDA) or better for ≥3 months who were treated with bDMARDs, the interval between bDMARD injections was extended 1.5 times, and treatment continuation rates at 104 weeks were calculated for each drug.

Contribution of bacterial pathogens to evoking serological disease markers and aggravating disease activity in rheumatoid arthritis.

Unlabelled: Commensal bacteria and their pathogenic components in the gastrointestinal tract and oral cavity may play pathological roles in autoimmune diseases. To study the possible involvement of bacterial pathogens in autoimmune diseases, IgG and IgA antibodies against pathogenic components produced by three strains of commensal bacteria, Escherichia coli-lipopolysaccharide (E. coli-LPS), Porphyromonas gingivalis-LPS (Pg-LPS) and peptidoglycan polysaccharide (PG-PS) from Streptococcus pyogenes, were determined by an improved ELISA system for sera from two groups of patients with rheumatoid arthritis (RA), who met rapid radiographic progression (RRP) criteria and non-RRP, and compared to normal (NL) controls.

Computer-Based Radiographic Quantification of Joint Space Narrowing Progression Using Sequential Hand Radiographs: Validation Study in Rheumatoid Arthritis Patients from Multiple Institutions.

We have developed a refined computer-based method to detect joint space narrowing (JSN) progression with the joint space narrowing progression index (JSNPI) by superimposing sequential hand radiographs. The purpose of this study is to assess the validity of a computer-based method using images obtained from multiple institutions in rheumatoid arthritis (RA) patients. Sequential hand radiographs of 42 patients (37 females and 5 males) with RA from two institutions were analyzed by a computer-based method and visual scoring systems as a standard of reference.

Effectiveness of golimumab for rheumatoid arthritis in patients with an inadequate response to tocilizumab.

Objectives: Several biological disease-modifying antirheumatic drugs (bDMARDs) are currently available for the treatment of rheumatoid arthritis (RA). Increasing evidence indicates that second-line bDMARDs are effective for inadequate responders to first-line bDMARDs. However, all previous studies investigated the use of tumor necrosis factor inhibitors (TNFi) as a first-line bDMARD, while investigated the efficacy of second-line bDMARDs after the use of tocilizumab (TCZ), a non-TNFi, as a first-line bDMARD.

One-year maintenance with routine assessment of patient index data 3-based remission may inhibit radiographic progression in patients with rheumatoid arthritis treated with routine clinical therapy: A retrospective comparison of radiographic outcome and its prognostic factors between maintained remissions with patient-reported outcome index and physician-oriented disease activity indices.

Objectives: We investigated whether the maintenance of routine assessment of patient index data 3 (RAPID3) remission for one year (RAPID3-MR) may predict good radiographic outcomes. We also compared radiographic progression to prognostic factors among patients with RAPID3-MR, with the maintenance of clinical disease activity index remission for one year (CDAI-MR) or with the maintenance of 28 joint count disease activity score remission for one year (DAS28-MR).

Methods: Of 1220 patients with available clinical data, 92 with RAPID3-MR, 80 with RAPID3-NMR (not satisfying RAPID3-MR), 45 with CDAI-MR, and 75 with DAS28-MR were retrospectively investigated.

Radiographic quantifications of joint space narrowing progression by computer-based approach using temporal subtraction in rheumatoid wrist.

Objective: To investigate the validity of a computer-based method using temporal subtraction in carpal joints of patients with rheumatoid arthritis (RA), which can detect the difference in joint space between two images with the joint space difference index (JSDI).

Methods: The study consisted of 43 patients with RA (39 females and 4 males) who underwent radiography at baseline and at 1-year follow-up. The joint space narrowing (JSN) of carpal joints on bilateral hand radiographs was assessed by our computer-based method, using the Sharp/van der Heijde method as the standard of reference.

Performance of computer-based analysis using temporal subtraction to assess joint space narrowing progression in rheumatoid patients.

Our computer-based method can detect the chronological change in joint space width between baseline and follow-up images as the joint space difference index (JSDI). The aim of this study was to verify the sensitivity and specificity of our computer-based method in assessment of joint space narrowing progression in rheumatoid patients. Twenty-seven patients (24 women and 3 men) with rheumatoid arthritis underwent radiography of the bilateral hand at baseline and at 1 year.

The usefulness of a new triple combination treatment utilizing methotrexate, salazosulfapyridine, and bucillamine in rheumatoid arthritis.

Objectives: Combination treatment with methotrexate, salazosulfapyridine and bucillamine as an alternative to treatment with TNF-inhibiting biologics in rheumatoid arthritis was investigated.

Methods: Twenty-six facilities allied with the Japan Association of Rheumatologists in Private Practice participated in this study. One hundred and twelve patients enrolled in this study, all of whom were within 3 years of diagnosis with rheumatoid arthritis for whom treatment with one DMARD or a combination of two DMARDs had failed (DAS28 > 3.

Inhibition of radiographic joint damage in rheumatoid arthritis patients in DAS28 remission using single- or combined with methotrexate non biological disease-modifying antirheumatic drug therapy in routine clinical practice.

Objective: We retrospectively investigated the inhibitory effect on radiographic joint damage (RJD) for non-biological disease-modifying antirheumatic drug (non-bioDMARD) monotherapy or methotrexate (MTX) combination therapy for rheumatoid arthritis (RA) in the disease activity score with 28 joint counts with erythrocyte sedimentation rate (DAS28) remission.

Methods: Eighty-four patients (55 cases of monotherapy, 29 cases of MTX-combination therapy) in DAS28 remission (DAS28 ≤ 2.6) were investigated from 538 RA patients newly registered between February 2007 and August 2010.

Safety and efficacy of combination therapy of iguratimod with methotrexate for patients with active rheumatoid arthritis with an inadequate response to methotrexate: an open-label extension of a randomized, double-blind, placebo-controlled trial.

Objective: To obtain safety and efficacy data on combination treatment with iguratimod and methotrexate (MTX) in an open-label extension study in patients with active rheumatoid arthritis (RA).

Methods: Following a 28-week, randomized, double-blind trial of adding iguratimod or placebo to stable MTX therapy, patients entered a 24-week extension. Patients randomized to the iguratimod + MTX group continued treatment.

Concomitant iguratimod therapy in patients with active rheumatoid arthritis despite stable doses of methotrexate: a randomized, double-blind, placebo-controlled trial.

Objectives: To investigate the efficacy and safety of iguratimod (T-614) in Japanese patients with active rheumatoid arthritis who had inadequate response to stable background methotrexate (MTX) alone.

Methods: In this multicenter, double-blind, controlled trial, a total of 253 patients were randomized at 2:1 ratio to either the iguratimod group or the placebo group. Iguratimod was orally administered at dosages of 25 mg/day for the first 4 weeks (25 mg once daily) and 50 mg/day for the subsequent 20 weeks (25 mg twice daily).

Radiological classification of glenoid deformity in rheumatoid arthritis.

We report a classification system based on the changes in shape of the glenoid fossa and on an evaluation of the upward migration of the humeral head, because a simple classification based on X-ray evaluation would be of great assistance to physicians dealing with the diagnosis and treatment of RA. We evaluated 150 shoulders of 118 RA patients who showed changes in the glenoid fossa after radiological examinations. The morphology of the glenoid fossa of the RA shoulder was classified into 3 types and we were able to classify a total of six types of deformities by adding the problem of upward migration of the humeral head.

Tacrolimus-induced pulmonary injury in rheumatoid arthritis patients.

Background: Tacrolimus (TAC) was approved in Japan in 2005 for rheumatoid arthritis (RA) patients having inadequate response to other disease-modifying anti-rheumatic drugs. As of May 2007, spontaneous reports identified twenty-seven cases of exacerbation or new development of interstitial pneumonia among RA patients given TAC in Japan.

Objective: To describe the clinical and radiological characteristics of TAC-induced pulmonary injury (TIPI).

Supplemental treatment of rheumatoid arthritis with natural milk antibodies against enteromicrobes and their toxins: results of an open-labelled pilot study.

Background: Environmental factors, particularly commensal bacteria in the gastrointestinal tract, may be involved in the pathogenesis of rheumatoid arthritis (RA). The aim of this study was to evaluate whether natural milk antibodies against a wide spectrum of pathogenic enteromicobes and their toxins modify the disease activity in RA.

Methods: Twenty patients with RA, whose disease activity was uncontrolled by authentic medications due to drug resistance, complications and/or risk factors were treated for 3 months with an oral administration of a whey protein concentrate (WPC) containing high levels of natural milk antibodies.

Long-term efficacy of leflunomide on disease activity and inhibition of joint damage: retrospective comparison with methotrexate for Japanese rheumatoid arthritis patients.

We retrospectively compared treatment impact with leflunomide (LEF) or methotrexate (MTX) on retarding joint damage and clinical symptom including a 28-joint-count Disease Activity Score/erythrocyte sedimentation rate (DAS28-ESR) between two similar groups in patients with rheumatoid arthritis (RA) over an approximately 3-year treatment. One group included 29 patients treated with LEF alone (average dose 16.1 mg/day); the other group included 26 patients treated with MTX (average dose 7.

Effects of an oral administration of glucosamine-chondroitin-quercetin glucoside on the synovial fluid properties in patients with osteoarthritis and rheumatoid arthritis.

The effects of an orally administered combination of a glucosamine-chondroitin-quercetin glucoside (GCQG) supplement on the synovial fluid properties of patients with osteoarthritis (OA) and rheumatoid arthritis (RA) were investigated from the clinical nutrition view point. In this study, forty-six OA and twenty-two RA patients were administered with the GCQG supplement orally for 3 months. Several parameters of the knee joints were monitored before and after supplementation.

Effects of bisphosphonates on fracture incidence and bone metabolism in rheumatoid arthritis patients in general practice taking long-term corticosteroid therapy: a retrospective study.

Background And Objective: There is a risk that disturbances of activities of daily living (ADL) due to rheumatoid arthritis (RA) are increased by the occurrence of fractures, including vertebral compression fractures and femoral neck fractures, in RA patients receiving oral corticosteroid therapy. Bisphosphonates are most commonly used in the treatment of postmenopausal osteoporosis. In a large-scale, randomized, double-blind, placebo-controlled study that was performed to assess the prophylactic efficacy of bisphosphonates, alendronic acid decreased the incidence of vertebral fractures by approximately 50% compared with placebo in postmenopausal patients.